Infusion pump systems and methods

ABSTRACT

Some embodiments an infusion pump system can be used to determine a user&#39;s total insulin load (TIL) that provides an accurate indication of the insulin previously delivered to the user&#39;s body which has not yet acted. In particular embodiments, the TIL can account for both the bolus deliveries and the basal deliveries that have occurred over a period of time. Such information may be useful, for example, when the infusion pump is operated in conjunction with a continuous glucose monitoring device.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This is a continuation of U.S. application Ser. No. 13/071,061 filed onMar. 24, 2011, now U.S. Pat. No. 8,221,385, which is a divisional ofU.S. application Ser. No. 12/195,034 filed on Aug. 20, 2008, now U.S.Pat. No. 7,959,598 the entire contents of these previous applicationsare expressly incorporated herein by reference.

TECHNICAL FIELD

This disclosure relates to portable infusion pump systems to deliverfluids, such as insulin infusion pump systems or the like.

BACKGROUND

Pump devices are commonly used to deliver one or more fluids to atargeted individual. For example, a medical infusion pump device may beused to deliver a medicine to a patient as part of a medical treatment.The medicine that is delivered by the infusion pump device can depend onthe condition of the patient and the desired treatment plan. Forexample, infusion pump devices have been used to deliver insulin to thevasculature of diabetes patients so as to regulate blood-glucose levels.In some circumstances, the dosage of medicine delivered by the infusionpump acts within the patient's body over a long period of time. Suchconditions, for example, may cause a patient to have an amount ofnon-activated insulin in his or her system even thought the infusionpump is programmed to deliver the next dosage in a series of insulindosages.

SUMMARY

Some embodiments an infusion pump system can be used to determine auser's total insulin load (TIL) that provides an accurate indication ofthe insulin already delivered to the user's body which has not yetacted. In particular embodiments, the TIL can account for both the bolusdeliveries and the basal deliveries that have occurred over a period oftime. Such information can be valuable to a user when the infusion pumpis operated in conjunction with a glucose monitoring device worn by theuser. Moreover, the TIL information can be readily displayed to the useras a quick reference of his or her status. For example, the infusionpump system can include a user interface that contemporaneously displaysthe user's blood glucose value and the total insulin load, therebyenabling the user to make informed decisions regarding the current andfuture status of his or her blood glucose level.

In particular embodiments, a medical infusion pump system may include aportable pump housing that receives insulin for dispensation to a user.The pump housing may at least partially contain a pump drive system todispense the insulin through a flow path to the user. The pump systemalso may include a controller that activates the pump drive system todispense the insulin from the portable pump housing. The pump system mayfurther include a monitoring device that communicates glucoseinformation to the controller. The glucose information may be indicativeof a blood glucose level of the user. The pump system also may include auser interface coupled to the controller including a display device thatcontemporaneously displays a glucose value indicative of the bloodglucose level of the user and a total insulin load indicative of bolusand basal insulin dosages that have dispensed but not yet acted in theuser.

Some embodiments of a method of operating an insulin infusion pumpsystem may include determining a total insulin load for a particulartime that accounts for a bolus insulin load, a basal insulin load, and aprevious food component. The bolus insulin load may be indicative of oneor more bolus insulin dosages that have been dispensed into a user froma portable infusion pump system but not yet acted in the user. The basalinsulin load may be indicative of one or more basal insulin dosages thathave been dispensed into the user from the portable infusion pump systembut not yet acted in the user. The previous food component may be basedupon previous food intake that has not yet metabolized in the user. Themethod also may include storing a calculated value for the total insulinload and a time value for the particular time in a computer-readablememory device of the portable infusion pump system. The method mayfurther include displaying the calculated value for the total insulinload on a display device of the portable infusion pump system.

In certain embodiments, a method of operating an insulin infusion pumpsystem may include receiving user input indicative of a request tosuggest a bolus dosage. The method may also include receiving user inputindicative of a proposed food intake to be consumed by a user of aportable infusion pump system. The method may further include receivingglucose information indicative of a glucose level of the user. Also, themethod may include determining a bolus suggestion value according to afunction that includes a total insulin load of the user. The totalinsulin load may account for (i) a bolus insulin load indicative of oneor more bolus insulin dosages that have been dispensed into the user butnot yet acted in the user, (ii) a basal insulin load indicative of oneor more basal insulin dosages that have been dispensed into the userfrom the portable infusion pump system but not yet acted in the user;and (iii) a previous food component based upon previous food intake thathas not yet metabolized in the user. The method may also includedisplaying the bolus suggestion value on a display device of theportable infusion pump system.

These and other embodiments described herein may provide one or more ofthe following advantages. First, the infusion pump system can be used toprovide a TIL value that accurately estimates the amount of previouslydelivered insulin that has not yet acted in the user's body. Forexample, the TIL can be determined in a manner that accounts for boththe bolus deliveries and the basal deliveries (not merely previous bolusdeliveries). As such, the TIL values may accurately reflect basal ratechanges and the impact of stopping insulin delivery or changing basaldelivery for a short period of time (e.g., a temporary basal ratechange). Also, in particular embodiments, the TIL can account for theuser's previously consumed food in addition to the bolus deliveries andthe basal deliveries. In these circumstances, the TIL values mayaccurately reflect both the previously dispensed insulin that has notyet acted and the previously consumed food that has not yet beenmetabolized. Second, the TIL information provided by the infusion pumpsystem can provide the user with opportunities for informeddecision-making when the infusion pump is operated in conjunction with acontinuous glucose monitoring device. For example, the infusion pumpsystem can include a user interface that contemporaneously displays theuser's blood glucose value and the total insulin load, thereby enablingthe user to make informed decisions regarding the current and futurestatus of his or her blood glucose level. Third, the infusion pumpsystem can include a bolus suggestion feature that accounts for theuser's TIL when suggesting a new bolus of insulin prior to a meal ofother food intake. For example, in response to a user's request, theinfusion pump system may communicate a suggested bolus dosage of insulinthat is calculated to account for the meal of other food to be consumed(e.g., a food bolus), the current difference between the user's actualblood glucose level and the targeted blood glucose level (e.g., acorrection bolus), and the amount of previous basal and bolus insulinthat has not yet acted in the user's body (e.g., a TIL factor).

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of an infusion pump system in accordancewith some embodiments.

FIG. 2 is a perspective exploded view of an infusion pump assembly ofthe system of FIG. 1.

FIG. 3 is a perspective view of the infusion pump system of FIG. 1 inwhich the pump assembly is worn on clothing of a user, in accordancewith particular embodiments.

FIG. 4 is a perspective view of an infusion pump system of FIG. 1 inwhich the pump assembly is worn on skin of a user, in accordance withother embodiments.

FIGS. 5-6 are perspective views of a pump device being detached from acontroller device of the system of FIG. 1, in accordance with someembodiments.

FIGS. 7-8 are perspective views of the pump device of FIGS. 5-6 beingdiscarded and the controller device of FIGS. 5-6 being reused with a newpump device.

FIG. 9 is an exploded perspective view of a controller device for aninfusion pump system, in accordance with some embodiments.

FIG. 10 is a perspective view of a portion of a pump device for aninfusion pump system, in accordance with particular embodiments.

FIG. 11 is a flow diagram depicting an exemplary process used todetermine a user's total insulin load (TIL), in accordance with someembodiments.

FIG. 12 is a diagram depicting an example of an insulin decay curve,which may be employed in the determination of the user's TIL inaccordance with some embodiments.

FIG. 13 is a diagram depicting an example of an insulin delivery pattern(constant basal delivery rate only) and a user's corresponding TIL andTIL % values, in accordance with some embodiments.

FIG. 14 is a diagram depicting an example of an insulin delivery pattern(constant basal delivery rate plus selected bolus deliveries) and auser's corresponding TIL and TIL % values, in accordance with someembodiments.

FIG. 15 is a diagram depicting an example of an insulin delivery pattern(intermittent basal delivery plus selected bolus deliveries) andcorresponding TIL and TIL %, in accordance with some embodiments.

FIG. 16A is a diagram depicting an example of an insulin deliverypattern (intermittent basal delivery plus selected bolus deliveries) anda user's corresponding TIL and TIL % values, in accordance with someembodiments.

FIG. 16B is a diagram depicting an example of insulin delivery pattern(intermittent basal delivery plus selected bolus deliveries) and auser's corresponding TIL and TIL % values that account for a previouslyconsumed food component, in accordance with some embodiments.

FIG. 17 is a flow diagram depicting an exemplary process used todetermine a bolus suggestion, in accordance with some embodiments.

FIG. 18 is a perspective view of an infusion pump assembly connected toan external computer for displaying a plot of TIL data received from theinfusion pump assembly, in accordance with some embodiments.

FIG. 19 is a perspective view of an infusion pump assembly displaying aplot of TIL data on a display device, in accordance with someembodiments.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION

Referring to FIG. 1, an infusion pump system 10 can include a pumpassembly 60 used to supply insulin or other medication to a user via,for example, an infusion set 70. In some embodiments, a glucosemonitoring device 50 can be in communication with the infusion pumpassembly 60 for the purpose of supplying data indicative of a user'sblood glucose level to a controller device 200 included in the pumpassembly 60. The infusion pump system 10 can be configured to supply asubstantially continuous basal rate of insulin (or other medication)with user-selected bolus dosages. The basal rate can be selected tomaintain a user's blood glucose level in a target range during normalactivity when the user is not eating or otherwise consuming food items,and the selected bolus deliveries may provide substantially largeramounts of insulin to limit the blood glucose level during certaincircumstances, such as the consumption of carbohydrates and other fooditems. The basal and bolus insulin dispensed into the user's system mayact over a period of time to control the user's blood glucose level. Assuch, the user's body may include some amount of insulin that has notyet acted even while the infusion pump assembly 60 is activated todeliver additional dosages (basal, bolus, or both). In thesecircumstances, the infusion pump assembly 60 can be used to determine auser's total insulin load (TIL) that provides an accurate indication ofthe insulin which has not yet acted in the user's body. For example, asshown in FIG. 1, the controller device 200 of the infusion pump assembly60 can include a user interface 220 configured to calculate and displaythe TIL value along with the user's blood glucose value, therebyenabling the user to make informed decisions regarding the current andfuture status of his or her blood glucose level.

The TIL information provided by the controller device 200 can bedetermined in a manner that accounts for both the bolus deliveries andthe basal deliveries (not merely bolus deliveries alone). As describedin more detail below, this process for determining the TIL value canaccurately reflect basal rate changes and the effects from stoppinginsulin delivery or changing basal delivery for a short period of time(e.g., a temporary basal rate change). Also, in further embodiments, theTIL information provided by the controller device 200 can be determinedin a manner that accounts for the user's previously consumed food (alongwith the previous basal and bolus deliveries). As described in moredetail below, such a process for determining the TIL value can revealthe effects from both the previously dispensed insulin that has not yetacted and the previously consumed food that has not yet beenmetabolized. In some embodiments, data related to the TIL, such as totalinsulin load values and the times at which they were calculated, can bestored in a memory device (described below) of the controller device200. This data can be used, for example, by the controller device 200 ina process to suggest a new bolus dosage based in response a user'srequest. For example, the bolus suggestion value can be based, at leastin part, on a user's current blood glucose level, food informationsupplied by the user (e.g., proposed food intake), and a recentlycalculated TIL value for the user. Moreover, the TIL data stored in thememory device of the controller 200 can be exported to an externalcomputer system for analysis by a physician, the user, or both. Forexample, as described in more detail below, the TIL data can bepresented in a plot format to assist the user and physician in makingadjustments to the user's insulin delivery patterns or food intake toimprove management the user's blood glucose level.

Still referring to FIG. 1, the glucose monitoring device 50 can includea housing 52, a wireless communication device 54, and a sensor shaft 56.The wireless communication device 54 can be contained within the housing52 and the sensor shaft 56 can extend outward from the housing 52. Inuse, the sensor shaft 56 can penetrate the skin 20 of a user to makemeasurements indicative of characteristics of the user's blood (e.g.,the user's blood glucose level or the like). In response to themeasurements made by the sensor shaft 56, the glucose monitoring device50 can employ the wireless communication device 54 to transmit data tothe controller device 200 of the pump assembly 60.

In some embodiments, the monitoring device 50 may include a circuit thatpermits sensor signals (e.g., data from the sensor shaft 56) to becommunicated to the communication device 54. The communication device 54can transfer the collected data to the infusion pump assembly 60 (e.g.,by wireless communication to a communication device 247 arranged in thepump assembly 60). In some embodiments, the monitoring device 50 canemploy other methods of obtaining information indicative of a user'sblood characteristics and transferring that information to the infusionpump assembly 60. For example, an alternative monitoring device mayemploy a micropore system in which a laser porator creates tiny holes inthe uppermost layer of a user's skin, through which interstitial glucoseis measured using a patch. Alternatively, the monitoring device can useiontophoretic methods to non-invasively extract interstitial glucose formeasurement. In other examples, the monitoring device can includenon-invasive detection systems that employ near IR, ultrasound orspectroscopy, and particular embodiments of glucose-sensing contactlenses. Invasive methods involving optical means of measuring glucosecould also be added. In yet another example, the monitoring device caninclude an optical detection instrument that is inserted through theskin for measuring the user's glucose level.

Furthermore, it should be understood that in some embodiments, themonitoring device 50 can be in communication with the pump assembly 60via a wired connection. In other embodiments of the pump system 10, teststrips (e.g., blood test strips) containing a sample of the user's bloodcan be inserted into a strip reader portion of the pump assembly 60 tobe tested for characteristics of the user's blood. Alternatively, thetest strips (e.g., glucose test strips) containing a sample of theuser's blood can be inserted into a glucose meter device (not shown inFIG. 1), which then analyzes the characteristics of the user's blood andcommunicates the information (via a wired or wireless connection) to thepump assembly 60. In still other embodiments, characteristics of theuser's blood glucose information can be entered directly into the pumpsystem 10 via a user interface on the controller device 200.

Referring now to FIGS. 1-2, the infusion pump assembly 60 can include apump device 100 and the controller device 200 that communicates with thepump device 100. The pump device 100 includes a housing structure 110that defines a cavity 116 in which a fluid cartridge 120 can bereceived. The pump device 100 also includes a cap device 130 to retainthe fluid cartridge 120 in the cavity 116 of the housing structure 110.The pump device 100 includes a drive system (described in more detailbelow in connection with FIG. 10) that advances a plunger 125 in thefluid cartridge 120 so as to dispense fluid therefrom. In someembodiments, the dispensed fluid exits the fluid cartridge 120, passesthrough a flexible tube 72 of the infusion set 70 to a cannula housing74. The dispensed fluid can enter through the skin via a cannula 76attached to the underside of the cannula housing 74.

In some embodiments, the controller device 200 communicates with thepump device 100 to control the operation of the pump drive system. Whenthe controller device 200, the pump device 100 (including the cap device130 in this embodiment), and the fluid cartridge 120 are assembledtogether, the user may conveniently wear the infusion pump assembly 60on the user's skin under clothing or in the user's pocket whilereceiving the fluid dispensed from the pump device 100 (refer, forexample, to FIGS. 3-4). Thus, in some embodiments, the pump assembly canoperate as a portable unit that provides reliable delivery of insulin oranother medication in a discrete manner.

As described in more detail below, the controller device 200 may beconfigured as a reusable component that provides electronics and a userinterface to control the operation of the pump device 100. In suchcircumstances, the pump device 100 can be a disposable component that isdisposed of after a single use. For example, the pump device 100 can bea “one time use” component that is thrown away after the fluid cartridge120 therein is exhausted. Thereafter, the user can removably attach anew pump device 100 to the reusable controller device 200 for thedispensation of fluid from a new fluid cartridge 120. Accordingly, theuser is permitted to reuse the controller device 200 (which may includecomplex or valuable electronics) while disposing of the relativelylow-cost pump device 100 after each use. Such a pump assembly 60 canprovide enhanced user safety as a new pump device 100 (and drive systemtherein) is employed with each new fluid cartridge 120.

Briefly, in use, the pump device 100 can be configured to removablyattach to the controller device 200 in a manner that provides a securefitting, an overall compact size, and a reliable electrical connection.The compact size permits the infusion pump assembly 60 to be discreteand portable. As described in more detail below, the controller device200 of the infusion pump system can be used to provide TIL informationthat accurately estimates the amount of previously delivered insulinthat has not yet acted in the user's body. In these embodiments, the TILinformation can provide the user with opportunities for informeddecision-making when the pump assembly 60 is operated in conjunctionwith the monitoring device 50. In addition, the controller device 200can provide a bolus suggestion feature that accounts for the user's TILwhen suggesting a new bolus of insulin prior to a meal of other foodintake. Because the bolus suggestion feature accounts for the amount ofprevious basal and bolus insulin that has not yet acted in the user'sbody, the controller device 200 can provide a suitable bolus suggestionamount that generally avoids excessive stacking of insulin doses.

It should be understood that, in alternative embodiments, the pumpdevice 100 and the controller device 200 can be configured as a singleunit in which the control components and the pump drive system arearranged in a single housing. In these alternative embodiments, the pumpassembly (including the controller device and the pump device) may havea different size and shape and may operate as a reusable unit that cancommunicate with a number of monitoring devices 50 over a period oftime.

Referring again to FIGS. 1-2, in some embodiments, the pump system 10 isa medical infusion pump system that is configured to controllablydispense a medicine from the cartridge 120. As such, the fluid cartridge120 may contain a medicine 126 to be infused into the tissue orvasculature of a targeted individual, such as a human or animal patient.For example, the pump device 100 can be adapted to receive a medicinecartridge 120 in the form of a carpule that is preloaded with insulin oranother medicine for use in the treatment of Diabetes (e.g., Byetta®,Symlin®, or others). Such a cartridge 120 may be supplied, for example,by Eli Lilly and Co. of Indianapolis, Ind. Other examples of medicinescontained in the fluid cartridge 120 include: pain relief drugs, hormonetherapy, blood pressure treatments, anti-emetics, osteoporosistreatments, or other injectable medicines. The medicine dispensed fromthe cartridge 120 into the user's system may act over a period of timein the user's body. As such, the user's body may include some amount ofmedicine that has not yet acted even while the infusion pump assembly 60is activated to deliver additional dosages of the medicine (basal,bolus, or both). The infusion pump assembly 60 can be used to determinea user's total medicine load that provides an accurate indication of themedicine which has not yet acted in the user's body. The total medicineload can be determine by the controller device 200 in a manner thataccounts for both the bolus deliveries and the basal deliveries of themedicine (similar to the process for determining the total insulin loadas described below). It should be understood from the description hereinthat the fluid cartridge 120 may have a configuration other than thatdepicted in FIG. 2. For example, the fluid cartridge may have adifferent outer shape or a different reservoir volume. In anotherexample, the fluid cartridge may comprise a reservoir that is integralwith the pump housing structure 110 (e.g., the fluid cartridge can bedefined by one or more walls of the pump housing structure 110 thatsurround a plunger to define a reservoir in which the medicine isinjected or otherwise received).

In some embodiments, the pump device 100 may include one or morestructures that interfere with the removal of the medicine cartridge 120after the medicine cartridge 120 is inserted into the cavity 116. Forexample, as shown in FIG. 2, the pump housing structure 110 may includeone or more retainer wings 119 that at least partially extend into thecavity 116 to engage a portion of the medicine cartridge 120 when themedicine cartridge 120 is installed therein. In this embodiment, thepump housing structure 110 includes a pair of opposing retainer wings119 (only one is shown in the view in FIG. 2) that flex toward the innersurface of the cavity 116 during insertion of the medicine cartridge120. After the medicine cartridge is inserted to a particular depth, theretainer wings 119 are biased to flex outward (toward the center of thecavity 116) so that the retainer wings 119 engage a neck portion 129 ofthe medicine cartridge 120. This engagement with the retainer wings 119and the neck portion 129 hinder any attempts to remove the medicinecartridge 120 away from the pump device 100. Alternative embodiments caninclude other features and/or configurations to hinder the removal ofthe medicine cartridge 120.

Embodiments of the pump device 100 that hinder the removal of themedicine cartridge 120 may facilitate the “one-time-use” feature of thepump device 100. Because the retainer wings 119 can interfere withattempts to remove the medicine cartridge 120 from the pump device 100,the pump device 100 will be discarded along with the medicine cartridge120 after the medicine cartridge 120 is emptied, expired, or otherwiseexhausted. The retainer wings 119 may serve to hinder attempts to removethe exhausted medicine cartridge 120 and to insert a new medicinecartridge 120 into the previously used pump device 100. Accordingly, thepump device 100 may operate in a tamper-resistant and safe mannerbecause the pump device 100 can be designed with predetermined lifeexpectancy (e.g., the “one-time-use” feature in which the pump device isdiscarded after the medicine cartridge 120 is emptied, expired, orotherwise exhausted).

Still referring to FIGS. 1-2, the cap device 130 can be joined with thepump device 100 after the medicine cartridge is inserted in the cavity116. It should be understood that the cap device 130 may supplement orreplace the previously described retainer wings 119 by locking intoposition after joining with the pump housing 110, thereby hinderingremoval of the fluid cartridge 120 in the pump housing 110. As shown inFIGS. 1-2, the cap device 130 may include an output port 139 thatconnects with the tubing 72 for dispensation of the medicine to theuser. In some embodiments, the output port 139 may have an angledorientation such that a portion of the tubing extends transversely tothe central axis of the cartridge 120 and cap device 130. The outputport 139 can be configured to mate with tubing 72 of the infusion set 70(FIG. 1).

In some embodiments, the controller device 200 may be removably attachedto the pump device 100 so that the two components are mechanicallymounted to one another in a fixed relationship. Such a mechanicalmounting can form an electrical connection between the removablecontroller device 200 and the pump device 100. For example, thecontroller device 200 may be in electrical communication with a portionof a drive system (described in connection with FIG. 10) of the pumpdevice 100. As described in more detail below, the pump device 100includes a drive system that causes controlled dispensation of themedicine or other fluid from the cartridge 120. In some embodiments, thedrive system incrementally advances a piston rod longitudinally into thecartridge 120 so that the fluid is forced out of an output end 122. Theseptum 121 at the output end 122 of the fluid cartridge 120 can bepierced to permit fluid outflow when the cap device 130 is connected tothe pump housing structure 110. Thus, when the pump device 100 and thecontroller device 200 are attached and thereby electrically connected,the controller device 200 communicates electronic control signals via ahardwire-connection (e.g., electrical contacts or the like) to the drivesystem or other components of the pump device 100. In response to theelectrical control signals from the controller device 200, the drivesystem of the pump device 100 causes medicine to incrementally dispensefrom the medicine cartridge 120.

The controller device 200 may be configured to removably attach to thepump device 100, for example, in a side-by-side arrangement. The compactsize permits the infusion pump assembly 60 to be discrete and portablewhen the pump device 100 is attached with the controller device 200 (asshown in FIG. 1). In this embodiment, the controller device 200 includesa controller housing structure 210 having a number of features that areconfigured to mate with complementary features of the pump housingstructure 110 so as to form a releasable mechanical connection(described below in more detail in connection with FIGS. 5-7). Suchmating features of the pump housing structure 110 and the controllerhousing structure 210 can provide a secure connection when thecontroller device 200 is attached to the pump device 100

As shown in FIG. 2, the pump device 100 may include an electricalconnector 118 (e.g., having conductive pads, pins, or the like) that areexposed to the controller device 200 and that mate with a complementaryelectrical connector (refer to connector 218 in FIG. 6) on the adjacentface of the controller device 200. The electrical connectors 118 and 218provide the electrical communication between the control circuitry(refer, for example, to FIG. 9) housed in the controller device 200 andat least a portion of the drive system or other components of the pumpdevice 100. In some exemplary embodiments, the electrical connectors 118and 218 permit the transmission of electrical control signals to thepump device 100 and the reception of feedback signals (e.g., sensorsignals) from particular components within the pump device 100.Furthermore, as described in more detail below, the infusion pumpassembly 60 may include a gasket 140 that provides a seal which isresistant to migration of external contaminants when the pump device 100is attached to the controller device 200. Thus, in some embodiments, thepump device 100 and the controller device 200 can be assembled into awater resistant configuration that protects the electricalinterconnection from water migration (e.g., if the user encounters waterwhile carrying the pump assembly 60).

Referring again to FIGS. 1-2, the controller device 200 includes theuser interface 220 that permits a user to monitor the operation of thepump device 100. In some embodiments, the user interface 220 includes adisplay 222 and one or more user-selectable buttons (e.g., four buttons224 a, 224 b, 224 c, and 224 d in this embodiment). The display 222 mayinclude an active area in which numerals, text, symbols, images, or acombination thereof can be displayed (refer, for example, to FIG. 2).For example, the display 222 may be used to communicate a number ofstatus indicators, alarms, settings, and/or menu options for theinfusion pump system 10. In some embodiments, the display 222 canindicate the user's blood glucose level, an indication that the user'sblood glucose level is rising or falling, and the TIL information. Inthe example depicted in FIG. 1, the TIL information shown in the display222 is “2.2 U”, which indicates that approximately 2.2 units ofdispensed insulin (including previous basal and bolus dosages) has yetto act on the user's blood glucose level (in particular embodiments,after accounting for any previously consumed food that has not yet beenmetabolized). In this embodiment, the display 222 also indicates thatthe user's blood glucose level is currently at 180 mg/dl and is falling.

In some embodiments, the user may press one or more of the buttons 224a, 224 b, 224 c, and 224 d to shuffle through a number of menus orprogram screens that show particular status indicators, settings, and/ordata (e.g., review data that shows the medicine dispensing rate, thetotal amount of medicine dispensed in a given time period, the amount ofmedicine scheduled to be dispensed at a particular time or date, theapproximate amount of medicine remaining in the cartridge 120, or thelike). In some embodiments, the user can adjust the settings orotherwise program the controller device 200 by pressing one or morebuttons 224 a, 224 b, 224 c, and 224 d of the user interface 220. Forexample, in embodiments of the infusion pump system 10 configured todispense insulin, the user may press one or more of the buttons 224 a,224 b, 224 c, and 224 d to change the dispensation rate of insulin or torequest that a bolus of insulin be dispensed immediately or at ascheduled, later time.

The display 222 of the user interface 220 may be configured to displayquick reference information when no buttons 224 a, 224 b, 224 c, and 224d have been pressed. For example, as shown in FIG. 2, the active area ofthe display 222 can display the time (10:30 AM in this example), bloodglucose level (118 mg/dl in this example), an indication of whether theuser's blood glucose level is rising or falling (the upward arrowindicates a rising glucose level in this example, and the user's currentTIL information (a 10% load in this example, which represents anormalized value of the TIL calculation as described below in connectionwith FIGS. 13-16B). This information can be displayed for a period oftime after no button 224 a, 224 b, 224 c, and 224 d has been actuated(e.g., five seconds, 10 seconds, 30 seconds, 1 minute, 5 minutes, or thelike). Thereafter, the display 222 may enter sleep mode in which theactive area is blank, thereby conserving battery power. In addition orin the alternative, the active area can display particular devicesettings, such as the current dispensation rate or the total medicinedispensed, for a period of time after no button 224 a, 224 b, 224 c, or224 d has been actuated (e.g., five seconds, 10 seconds, 30 seconds, 1minute, 5 minutes, or the like). Again, thereafter the display 222 mayenter sleep mode to conserve battery power. In certain embodiments, thedisplay 222 can dim after a first period of time in which no button 224a, 224 b, 224 c, or 224 d has been actuated (e.g., after 15 seconds orthe like), and then the display 22 can enter sleep mode and become blankafter a second period of time in which no button 224 a, 224 b, 224 c, or224 d has been actuated (e.g., after 30 seconds or the like). Thus, thedimming of the display device 222 can alert a user viewing the displaydevice 222 when the active area 223 of the display device will soonbecome blank.

Accordingly, when the controller device 200 is connected to the pumpdevice 100, the user is provided with the opportunity to readily monitorinfusion pump operation by simply viewing the display 222 of thecontroller device 200. Such monitoring capabilities may provide comfortto a user who may have urgent questions about the current operation ofthe pump device 100 (e.g., the user may be unable to receive immediateanswers if wearing an infusion pump device having no user interfaceattached thereto). Moreover, the TIL information can be displayedcontemporaneously with the detected blood glucose value, so the user isprovided with the opportunity to make informed decisions regarding thecurrent and future status of his or her blood glucose level.

Also, in these embodiments, there may be no need for the user to carryand operate a separate module to monitor the operation of the infusionpump device 100, thereby simplifying the monitoring process and reducingthe number of devices that must be carried by the user. If a need arisesin which the user desires to monitor the operation of the pump device100 or to adjust settings of the pump system 10 (e.g., to request abolus amount of medicine), the user can readily operate the userinterface 220 of the controller device 200 without the requirement oflocating and operating a separate monitoring module.

In other embodiments, the user interface 200 is not limited to thedisplay and buttons depicted in FIGS. 1-2. For example, in someembodiments, the user interface 220 may include only one button or mayinclude a greater numbers of buttons, such as two buttons three buttons,four buttons, five buttons, or more. In another example, the userinterface 220 of the controller device 200 may include a touch screen sothat a user may select buttons defined by the active area of the touchscreen display. Alternatively, the user interface 220 may comprise audioinputs or outputs so that a user can monitor the operation of the pumpdevice 100.

Referring to FIGS. 3-4, the infusion pump system 10 may be configured tobe portable and can be wearable and concealable. For example, a user canconveniently wear the infusion pump assembly 60 on the user's skin(e.g., skin adhesive) underneath the user's clothing or carry the pumpassembly 60 in the user's pocket (or other portable location) whilereceiving the medicine dispensed from the pump device 100. The pumpdevice 100 may be arranged in a compact manner so that the pump device100 has a reduced length. For example, in the circumstances in which themedicine cartridge 120 has a length of about 7 cm or less, about 6 cm toabout 7 cm, and about 6.4 cm in one embodiment, the overall length ofthe pump housing structure 110 (which contains medicine cartridge andthe drive system) can be about 10 cm or less, about 7 cm to about 9 cm,and about 8.3 cm in one embodiment. In such circumstances, thecontroller device 200 can be figured to mate with the pump housing 110so that, when removably attached to one another, the components define aportable infusion pump system that stores a relatively large quantity ofmedicine compared to the overall size of the unit. For example, in thisembodiment, the infusion pump assembly 60 (including the removablecontroller device 200 attached to the pump device 100 having the cap130) may have an overall length of about 11 cm or less, about 7 cm toabout 10 cm, and about 9.6 cm in one embodiment; an overall height ofabout 6 cm or less, about 2 cm to about 5 cm, and about 4.3 cm in oneembodiment; and an overall thickness of about 20 mm or less, about 8 mmto about 20 mm, and about 18.3 mm in one embodiment.

The pump system 10 is shown in FIGS. 3-4 is compact so that the user canwear the portable infusion pump system 10 (e.g., in the user's pocket,connected to a belt clip, adhered to the user's skin, or the like)without the need for carrying and operating a separate module. In suchembodiments, the cap device 130 of the pump device 100 may be configuredto mate with the infusion set 70. In general, the infusion set 70 istubing system that connects the infusion pump system 10 to the tissue orvasculature of the user (e.g., to deliver medicine into the user'ssubcutaneous tissue or vasculature). The infusion set 70 may include theflexible tube 72 that extends from the pump device 100 to thesubcutaneous cannula 76 retained by a skin adhesive patch 78 thatsecures the subcutaneous cannula 76 to the infusion site. The skinadhesive patch 78 can retain the infusion cannula 76 in fluidcommunication with the tissue or vasculature of the patient so that themedicine dispensed through the tube 72 passes through the cannula 76 andinto the user's body. The cap device 130 may provide fluid communicationbetween the output end 122 (FIG. 2) of the medicine cartridge 120 andthe tube 72 of the infusion set 70. For example, the tube 72 may bedirectly connected to the output port 139 (FIG. 2) of the cap device130. In another example, the infusion set 70 may include a connector(e.g., a Luer connector or the like) attached to the tube 72, and theconnector can then mate with the cap device 130 to provide the fluidcommunication to the tube 72. In these examples, the user can carry theportable infusion pump assembly 60 (e.g., in the user's pocket,connected to a belt clip, adhered to the user's skin, or the like) whilethe tube 72 extends to the location in which the skin is penetrated forinfusion. If the user desires to monitor the operation of the pumpdevice 100 or to adjust the settings of the infusion pump system 10, theuser can readily access the user interface 220 of the controller device200 without the need for carrying and operating a separate module.

Referring to FIG. 3, in some embodiments, the infusion pump assembly 60is pocket-sized so that the pump device 100 and controller device 200can be worn in the user's pocket 6 or in another portion of the user'sclothing. For example, the pump device 100 and the controller device 200can be attached together and form the assembly 60 that comfortably fitsinto a user's pocket 6. The user can carry the portable infusion pumpassembly 60 and use the tube 72 of the infusion set 70 to direct thedispensed medicine to the desired infusion site. In some circumstances,the user may desire to wear the pump assembly 60 in a more discretemanner. Accordingly, the user may pass the tube 72 from the pocket 6,under the user's clothing, and to the infusion site where the adhesivepatch 78 is positioned. As such, the pump system 10 can be used todeliver medicine to the tissues or vasculature of the user in aportable, concealable, and discrete manner. Furthermore, the monitoringdevice 50 can be worn on the user's skin while the pump assembly 60 iscarried by the user (e.g., in a pocket). As such, the monitoring device50 can communicate information indicative of the user's blood glucoselevel to the pump assembly 60 while the pump assembly 60 is used todeliver medicine through the infusion set 70. In this embodiment, themonitoring device 50 may be arranged on the user's skin at a locationthat is spaced apart from the infusion set 70.

Referring to FIG. 4, in other embodiments, the infusion pump assembly 60may be configured to adhere to the user's skin 7 directly at thelocation in which the skin is penetrated for medicine infusion. Forexample, a rear surface of the pump device 100 may include a skinadhesive patch so that the pump device 100 is physically adhered to theskin of the user at a particular location. In these embodiments, the capdevice 130 may have a configuration in which medicine passes directlyfrom the cap device 130 into an infusion cannula 76 that is penetratedinto the user's skin. In one example, the fluid output port 139 throughthe cap device 130 can include a curve or a 90° corner so that themedicine flow path extends longitudinally out of the medicine cartridgeand thereafter laterally toward the patient's skin 7. Again, if the userdesires to monitor the operation of the pump device 100 or to adjust thesettings of the infusion pump system 10, the user can readily access theuser interface 220 of the controller device 200 without the need forcarrying and operating a second, separate device. For example, the usermay look toward the pump device 100 to view the user interface 220 ofthe controller device 200 that is removably attached thereto. In anotherexample, the user can temporarily detach the controller device 200(while the pump device 100 remains adhered to the skin 7) so as to viewand interact with the user interface 220. Furthermore, the monitoringdevice 50 can be worn on the user's skin while the pump assembly 60 isworn on the user's skin in a different location from that where themonitoring device is worn. As such, the monitoring device 50 cancommunicate information indicative of the user's blood glucose level tothe pump assembly 60 while the pump assembly 60 is used to delivermedicine through the infusion set 70. In this embodiment, the monitoringdevice 50 may be arranged on the user's skin at a location that isspaced apart from the infusion set 70.

In the embodiments depicted in FIGS. 3-4, the monitoring device 50adheres to the user's skin 7 at the location in which the skin ispenetrated by the sensor shaft 56 (to detect blood glucose levels). Thesensor shaft 56 (refer to FIG. 1) penetrates the skin surface for thepurpose of exposing the tip portion of the sensor shaft 56 to the tissueor the vasculature of the user. The sensor shaft 56 can detectinformation indicative of the user's blood glucose level and transferthis information to a circuit that is connected to the communicationsdevice 54 located within the monitoring device 50. The communicationdevice 54 can be in wireless communication with the communication device247 (described in connection with FIG. 9) included in the controllerdevice 200 of the pump assembly 60.

Referring now to FIGS. 5-8, in some embodiments, the infusion pumpassembly 60 can be operated such that the pump device 100 is adisposable, non-reusable component while the controller device 200 is areusable component. In these circumstances, the pump device 100 may beconfigured as a “one-time-use” device that is discarded after themedicine cartridge is emptied, expired, or otherwise exhausted. Thus, insome embodiments, the pump device 100 may be designed to have anexpected operational life of about 1 day to about 30 days, about 1 dayto about 20 days, about 1 to about 14 days, or about 1 day to about 7days—depending on the volume of medicine in the cartridge 120, thedispensation patterns that are selected for the individual user, andother factors. For example, in some embodiments, the medicine cartridge120 containing insulin may have an expected usage life about 7 daysafter the cartridge is removed from a refrigerated state and the septum121 (FIG. 2) is punctured. In some circumstances, the dispensationpattern selected by the user can cause the insulin to be emptied fromthe medicine cartridge 120 before the 7-day period. If the insulin isnot emptied from the medicine cartridge 120 after the 7-day period, theremaining insulin may become expired sometime thereafter. In eithercase, the pump device 100 and the medicine cartridge 120 therein can bediscarded after exhaustion of the medicine cartridge 120 (e.g., afterbeing emptied, expired, or otherwise not available for use).

The controller device 200, however, may be reused with subsequent newpump devices 100′ and new medicine cartridges 120′. As such, the controlcircuitry, the user interface components, and other components that mayhave relatively higher manufacturing costs can be reused over a longerperiod of time. For example, in some embodiments, the controller device200 may be designed to have an expected operational life of about 1 yearto about 7 years, about 2 years to about 6 years, or about 3 years toabout 5 years—depending on a number of factors including the usageconditions for the individual user. Accordingly, the user is permittedto reuse the controller device 200 (which may include complex orvaluable electronics) while disposing of the relatively low-cost pumpdevice 100 after each use. Such a pump system 10 can provide enhanceduser safety as a new pump device 100′ (and drive system therein) isemployed with each new fluid cartridge 120.

Referring to FIGS. 5-6, the pump device 100 can be readily removed fromthe controller device 200 when the medicine cartridge 120 is exhausted.As previously described, the medicine cartridge 120 is arranged in thecavity 116 (FIG. 2) of the pump housing 110 where it is retained by thecap device 130. In some embodiments, a portion of the pump housing 110can comprise a transparent or translucent material so that at least aportion of the medicine cartridge 120 is viewable therethrough. Forexample, the user may want to visually inspect the medicine cartridgewhen the plunger 125 is approaching the output end 122 of the medicinecartridge, thereby providing a visual indication that the medicinecartridge may be emptied in the near future. In this embodiment, thebarrel 111 of the pump housing 110 comprises a generally transparentpolymer material so that the user can view the medicine cartridge 120 todetermine if the plunger 125 is nearing the end of its travel length.

As shown in FIG. 5, the pump device 100 has been used to a point atwhich the medicine cartridge 120 is exhausted. The plunger 125 has beenadvanced, toward the left in FIG. 5, over a period of time so that allor most of the medicine has been dispensed from the cartridge 120. Insome embodiments, the controller device 200 may provide a visual oraudible alert when this occurs so as to remind the user that a newmedicine cartridge is needed. In addition or in the alternative, theuser may visually inspect the medicine cartridge 120 through the barrel111 of the pump housing 110 to determine if the medicine cartridge 120is almost empty. When the user determines that a new medicine cartridge120 should be employed, the pump device 100 can be readily separatedfrom the controller device 200 by actuating a release member 215. Inthis embodiment, the release member 215 is a latch on the controllerdevice 200 that is biased toward a locking position to engage the pumpdevice 100. The latch may be arranged to engage one or more features ona lateral side of the pump housing 110. As such, the user may actuatethe release member 215 by moving the release member 215 in a lateraldirection 216 (FIG. 5) away from the pump device 100 (e.g., by applyinga force with the user's finger).

As shown in FIG. 6, when the release member 215 is actuated and moved toa position away from the pump device 100, a segmented guide rail 114 a-bis free to slide longitudinally in a guide channel 214 a-b withoutinterference from the release member 215. Accordingly, the user can movethe pump device 100 in a longitudinal direction 217 away from thecontroller device 200. For example, the segmented guide rail 114 a-b mayslide along the guide channel 214 a-b, the extension 113 (FIG. 2) may bewithdrawn from the mating depression 213 (FIG. 6), and the electricalconnector 118 can be separated from the mating connector 218. In thesecircumstances, the pump device 100 is physically and electricallydisconnected from the controller device 200 while the pump deviceretains the exhausted medicine cartridge 120. It should be understoodthat, in other embodiments, other features or connector devices can beused to facilitate the side-by-side mounting arrangement. These otherfeatures or connector devices may include, for example, magneticattachment devices, mating tongues and grooves, or the like.

In some embodiments, the gasket 140 compressed between the pump device100 and the controller device 200 may comprise a resilient material. Insuch circumstances, the gasket 140 can provide a spring-action thaturges the pump device 100 to shift a small amount away from thecontroller device 200 when the release member 215 is moved to theunlocked position (e.g., moved in the lateral direction 216 in theembodiment shown in FIG. 5). Accordingly, in some embodiments, the pumpdevice 100 can automatically and sharply move a small distance (e.g.,about 0.5 mm to about 5 mm) away from the controller device 200 when therelease member 215 is moved to the unlocked position. Such an automaticseparation provides a convenient start for the user to detach the pumpdevice 100 away from the controller device 200. Furthermore, thisautomatic separation caused by the spring-action of the gasket 140 canprovide a swift disconnect between the electrical connectors 118 and 218when the pump device 100 is being replaced.

Referring to FIGS. 7-8, the same controller device 200 can be reusedwith a new pump device 100′ having a new medicine cartridge 120′retained therein, and the previously used pump device 100 can bediscarded with the exhausted medicine cartridge 120. The new pump device100′ (FIG. 7) can have a similar appearance, form factor, and operationas the previously used pump device 100 (FIGS. 5-6), and thus the newpump device 100′ can be readily attached to the controller device 200for controlled dispensation of medicine from the new medicine cartridge120′. In some embodiments, the user may prepare the new pump device 100′for use with the controller device 200. For example, the user may insertthe new medicine cartridge 120′ in the cavity 116 of the new pump device100′ and then join the cap device 130 to the pump housing to retain thenew medicine cartridge 120′ therein (refer, for example, to FIG. 2).Although the tubing 72 of the infusion set 70 is not shown in FIG. 7, itshould be understood that the tubing 72 may be attached to the capdevice 130 prior to the cap device 130 being joined with the housing110. For example, a new infusion set 70 can be connected to the capdevice 130 so that the tubing 72 can be primed (e.g., a selectedfunction of the pump device 100 controlled by the controller device 200)before attaching the infusion set patch to the user's skin. As shown inFIG. 7, the new medicine cartridge 120′ may be filled with medicine suchthat the plunger 125 is not viewable through the barrel 111. In someembodiments, the user can removably attach the pump device 100 to thecontroller device 200 by moving the pump device 100 in a longitudinaldirection 219 toward the controller device 200 such that the segmentedguide rail 114 a-b engages and slides within the guide channel 214 a-b.When the electrical connectors 118 and 218 mate with one another, therelease member 215 can engage the segmented guide rails 114 a-b toretain the pump device 100 with the controller device 200.

As shown in FIG. 8, the previously used pump device 100 that wasseparated from the controller device (as described in connection withFIGS. 5-6) may be discarded after a single use. In these circumstances,the pump device 100 may be configured as a disposable “one-time-use”device that is discarded by the user after the medicine cartridge 120 isemptied, is expired, has ended its useful life, or is otherwiseexhausted. For example, the pump device 100 may be discarded into a bin30, which may include a trash bin or a bin specifically designated fordiscarded medical products. Thus, the user is permitted to dispose ofthe relatively low-cost pump device 100 after each use while reusing thecontroller device 200 (which may include complex or valuableelectronics) with subsequent new pumps 100′. Also, in somecircumstances, the infusion set 70 (not shown in FIG. 8, refer toFIG. 1) that was used with the pump device 100 may be removed from theuser and discarded into the bin 30 along with the pump device 100.Alternatively, the infusion set 70 can be disconnected from the previouspump device 100 and attached to the new pump device 100′. In thesecircumstances, the user may detach the infusion set cannula 76 and patch78 from the skin so as to “re-prime” the tubing with medicine from thenew pump device 100′ to remove air pockets from the tubing. Thereafter,the infusion set cannula 76 and patch 78 can be again secured to theuser's skin.

Referring now to FIG. 9, the controller device 200 (shown in an explodedview) houses a number of components that can be reused with a series ofsuccessive pump devices 100. In particular, the controller device 200includes control circuitry 240 arranged in the controller housing 210that is configured to communicate control signals to the drive system ofthe pump device 100. In this embodiment, the control circuitry 240includes a main processor board 242 that is in communication with apower supply board 244. The control circuitry 240 includes at least oneprocessor 243 that coordinates the electrical communication to and fromthe controller device 200 (e.g., communication between the controllerdevice 200 and the pump device 100). The processor 243 can be arrangedon the main processor board 242 along with a number of other electricalcomponents such as memory devices (e.g., memory chip 248). It should beunderstood that, although the main processor board 242 is depicted as aprinted circuit board, the main processor board can have other forms,including multiple boards, a flexible circuit substrate, and otherconfigurations that permit the processor 243 to operate. The controlcircuitry 240 can be programmable in that the user may provide one ormore instructions to adjust a number of settings for the operation ofthe infusion pump system 10. Such settings may be stored in the one oremore memory devices, such as the memory chip 248 on the processor board242. The control circuitry 240 may include other components, such assensors (e.g., occlusion sensors), that are electrically connected tothe main processor board 242. Furthermore, the control circuitry 240 mayinclude one or more dedicated memory devices that store executablesoftware instructions for the processor 243. The one or more memorydevices (e.g., the memory chip 248) can also store information relatedto a user's blood glucose level and total insulin load (described inmore detail in association with FIGS. 11-19) over a period of time.

As previously described, the controller device 200 can be electricallyconnected with the pump device 100 via mating connectors 118 and 218 sothat the control circuitry 240 can communicate control signals to thepump device 100 and receive feedback signals from components housed inthe pump device 100. In this embodiment, the electrical connector 118(FIG. 2) on the pump device 100 is a z-axis connector, and the connector218 (FIG. 6) on the controller device 200 is adapted to mate therewith.The electrical connector 218 on the controller device 200 is incommunication with the control circuitry 240. As such, the processor 243can operate according to software instructions stored in the memorydevice so as to send control signals to the pump device 100 via theconnector 218.

Still referring to FIG. 9, the user interface 220 of the controllerdevice 200 can include input components, output components, or both thatare electrically connected to the control circuitry 240. For example, inthis embodiment, the user interface 220 includes a display device 222having an active area that outputs information to a user and fourbuttons 224 a-d that receive input from the user. Here, the display 222may be used to communicate a number of status indicators, settings,and/or menu options for the infusion pump system 10. In someembodiments, the control circuitry 240 may receive the input commandsfrom the user's button selections and thereby cause the display device222 to output a number of status indicators (e.g., if the pump system 10is delivering insulin and/or if the user's blood glucose level is risingor falling), menus, and/or program screens that show particular settingsand data (e.g., review data that shows the medicine dispensing rate, thetotal amount of medicine dispensed in a given time period, the amount ofmedicine scheduled to be dispensed at a particular time or date, theapproximate amount of medicine remaining the cartridge 120, the user'stotal insulin load, or the like). As previously described, thecontroller circuit 240 can be programmable in that the input commandsfrom the button selections can cause the controller circuit 240 tochange any one of a number of settings for the infusion pump system 100.

Some embodiments of the control circuitry 240 may include a cableconnector (e.g., a USB connection port, another data cable port, or adata cable connection via the electrical connection 218) that isaccessible on an external portion of the controller housing 210. Assuch, a cable may be connected to the control circuitry 240 to uploaddata or program settings to the controller circuit or to download datafrom the control circuitry 240. For example, historical data of bloodglucose level, medicine delivery, and/or TIL information can bedownloaded from the control circuitry 240 (via the cable connector) to acomputer system of a physician or a user for purposes of analysis andprogram adjustments (refer, for example, to FIG. 18). Optionally, thedata cable may also provide recharging power.

Referring to FIGS. 9-10, the control circuitry 240 of the controllerdevice 200 may include a second power source 245 (FIG. 9) that canreceive electrical energy from a first power source 345 (FIG. 10) housedin the pump device 100. In this embodiment, the second power source 245is coupled to the power supply board 244 of the control circuitry 240.The hard-wired transmission of the electrical energy can occur throughthe previously described connectors 118 and 218. In such circumstances,the first power source 345 may include a high density battery that iscapable of providing a relatively large amount of electrical energy forits package size, while the second power source 245 may include a highcurrent-output battery that is capable discharging a brief current burstto power the drive system 300 of the pump device 100. Accordingly, thefirst battery 345 disposed in the pump device 100 can be used to deliverelectrical energy over time (e.g., “trickle charge”) to the secondbattery 245 when the controller device 200 is removably attached to thepump device 100. For example, the first battery 345 may comprise azinc-air cell battery. The zinc-air cell battery 345 may have a largevolumetric energy density compared to some other battery types. Also,the zinc-air cell battery may have a long storage life, especially inthose embodiments in which the battery is sealed (e.g., by a removableseal tab or the like) during storage and before activation.

The second battery 245 may include a high current-output device that ishoused inside the controller housing 210. The second battery 245 can becharged over a period of time by the first battery 345 and thenintermittently deliver bursts of high-current output to the drive system300 over a brief moment of time. For example, the second battery 245 maycomprise a lithium-polymer battery. The lithium-polymer battery 245disposed in the controller device 200 may have an initial current outputthat is greater than the zinc-air cell battery 345 disposed in the pumpdevice 100, but zinc-air cell battery 345 may have an energy densitythat is greater than the lithium-polymer battery 245. In addition, thelithium-polymer battery 245 is readily rechargeable, which permits thezinc-air battery 345 disposed in the pump device 100 to provideelectrical energy to the lithium-polymer battery 245 for purposes ofrecharging. In alternative embodiments, it should be understood that thesecond power source 245 may comprise a capacitor device capable of beingrecharged over time and intermittently discharging a current burst toactivate the drive system 105.

Accordingly, the infusion pump system 10 having two power sources 345and 245—one arranged in the pump device 100 and another arranged in thereusable controller device 200—permits a user to continually operate thecontroller device 200 without having to recharge a battery via an outletplug-in or other power cable. Because the controller device 200 can bereusable with a number of pump devices 100 (e.g., attach the new pumpdevice 100′ after the previous pump device 100 is expended anddisposed), the second power source 245 in the controller device can berecharged over a period of time each time a new pump device 100 isconnected thereto. Such a configuration can be advantageous in thoseembodiments in which the pump device 100 is configured to be adisposable, one-time-use device that attaches to a reusable controllerdevice 200. For example, in those embodiments, the “disposable” pumpdevices 100 recharge the second power source 245 in the “reusable”controller device 200, thereby reducing or possibly eliminating the needfor separate recharging of the controller device 200 via a power cordplugged into a wall outlet.

Referring now to FIG. 10, the pump device 100 in this embodimentincludes the drive system 300 that is controlled by the removablecontroller device 200 (see FIG. 2). Accordingly, the drive system 300can accurately and incrementally dispense fluid from the pump device 100in a controlled manner. The drive system 300 may include a flexiblepiston rod 370 that is incrementally advanced toward the medicinecartridge 120 so as to dispense the medicine from the pump device 100.At least a portion of the drive system 300 is mounted, in thisembodiment, to the pump housing 110. Some embodiments of the drivesystem 300 may include a battery powered actuator (e.g., reversiblemotor 320 or the like) that actuates a gear system 330 to reset aratchet mechanism (e.g., including a ratchet wheel and pawl), a springdevice (not shown) that provides the driving force to incrementallyadvance the ratchet mechanism, and a drive wheel 360 that is rotated bythe ratchet mechanism to advance the flexible piston rod 370 toward themedicine cartridge 120. Connected to piston rod 370 is a pusher disc 375for moving the plunger 125 of the medicine cartridge 120.

Some embodiments of the drive system 300 can include a pressure sensor380 disposed between the plunger engagement device 375 and the plunger125 for determining the pressure within the fluid path (e.g., inside themedicine cartridge 120, the infusion set 70, and the like). For example,the fluid pressure in the medicine cartridge 120 can act upon theplunger 125, which in turn can act upon the pressure sensor 380 arrangedon the dry side of the plunger 125. The pressure sensor 380 may comprisea pressure transducer that is electrically connected (via one or morewires) to a gateway circuit 318 so that the sensor signals can becommunicated to the controller device 200 (e.g., via the electricalconnectors 118 and 218). As such, data from the pressure sensor 380 canbe received by the controller device 200 for use with, for example, anocclusion detection module to determine if an occlusion exists in themedicine flow path. Alternatively, the controller device 200 may includean optical sensor system (not shown in FIGS. 9-10) to detect occlusionsin the fluid path. For example, a light emitter and light sensor mayeach be arranged on a sensor circuit in the controller device 200 (butaligned with the pump device 100) so that the light sensor can detectthe amount of light emitted by the light emitter and subsequentlyreflected from a component adjacent the fluid path. The reflected lightlevel detected may be used to determine the pressure within the fluidpath.

Referring now to FIG. 11, the infusion pump system 10 can be used todetermine a user's TIL at a particular point in time. For example, aprocess 400 for determining TIL information can be implemented by thecontroller device 200. As previously described, the pump assembly 60 canoperate to deliver insulin to the user by basal dosages, selected bolusdosages, or a combination thereof. A basal rate of insulin can bedelivered in an incremental manner (e.g., dispense 0.25 U every fifteenminutes for a rate of 1.0 U per hour) to help maintain the user's bloodglucose level within a targeted range during normal activity when theuser is not eating or otherwise consuming food items. The user mayselect one or more bolus deliveries, for example, to offset the bloodglucose effects caused by the intake of food or to correct for anundesirably high blood glucose level. In some circumstances, the basalrate pattern may be programmed by a health care professional during aclinical visit (or, optionally, by the user) and may remain at asubstantially constant rate for a long period of time (e.g., a firstbasal dispensation rate for a period of hours in the morning, and asecond basal dispensation rate for a period of hours in the afternoonand evening). In contrast, the bolus dosages can be dispensed inuser-selected amounts based on calculations made by the controllerdevice 200. For example, the controller device 200 can be informed of ahigh glucose level (e.g., by user input, data received from the glucosemonitoring device 50, or the like) and can make a suggestion to the userto administer a bolus of insulin to correct for the high blood glucosereading. In another example, the user can request that the controllerdevice 200 calculate and suggest a bolus dosage based, at least in part,on a proposed meal that the user plans to consume.

The basal and bolus insulin dispensed into the user's system may actover a period of time to control the user's blood glucose level. Assuch, the user's body may include some amount of insulin that has notyet acted even while the infusion pump assembly 60 is activated todeliver additional dosages (basal, bolus, or both). In thesecircumstances, the controller device 200 may implement a process 400(FIG. 11) to determine the user's total insulin load (TIL), which canprovide an accurate indication of the previously dispensed insulin (bothbasal and bolus dosages) which has not yet acted in the user's body. TheTIL information can be determined in a manner that accounts for thesubstantial delay between the time that insulin is delivered to thetissue of the subcutaneous region and the time that this insulin reachesthe blood supply. For example, the delay between a subcutaneous deliveryof a bolus dosage of insulin and the peak plasma insulin level achievedfrom this bolus can be one hour or more. Additionally, the bolus dosagemay not enter the blood stream all at once. As such, the effect of thebolus can peak at about one to two hours and then decay in a predictablemanner over as much as eight hours or more (described in more detail inconnection with FIG. 12). Due to the time decay effects of insulinactivity, the user could be susceptible to request a subsequent bolusdosage while some insulin from a previously delivered bolus dosage hasnot yet acted upon the user (a scenario sometimes referred to as “bolusstacking”). To reduce the likelihood of undesirable bolus stacking, theTIL information can be determined by the controller device 200 on aperiodic basis so that the user can be aware of the previously dispensedinsulin which has not yet acted in the user's body. As described in moredetail below, the TIL information can also be used in a bolus suggestionfeature of the controller device 200 so that the suggested bolus amountaccounts for the previously dispensed insulin (both basal and bolusdosages) which has not yet acted in the user's body.

For diabetics, their long term health may depend greatly on the abilityto accurately control their blood glucose levels under a wide variety ofconditions and to quickly and accurately respond to changes in bloodglucose level from, for example, changes in activity level, carbohydrateingestion, or the like. As such, it can be beneficial for a user toemploy the infusion pump system 10 that enables the user to makewell-informed decisions about future insulin boluses and basal rates.For example, the controller device 200 can readily indicate to the userhis or her current TIL information, which is generally more accuratethan other insulin estimation tools that are based on bolus dosagesalone. Also, the controller device 200 can be used to suggest futurebolus amounts based upon (1) actual and target blood glucose levels, (2)proposed food items to be consumed, and (3) the TIL informationdetermined in a manner that accounts for both the previous bolusdeliveries and the previous basal deliveries and (optionally) the user'spreviously consumed carbohydrates that have not yet been metabolized.

Referring in more detail to the illustrative process 400 shown in FIG.11, the process 400 for the determining of the TIL of a user can includea number of operations performed by the controller device 200. Inoperation 405, the controller device 200 can initiate a TIL calculationfor a particular time t_(n) based on, for example, a request by the user(e.g., on-demand calculation) or a controller routine that determinesthe TIL information on a periodic basis (e.g., every 1 minute, every 2minutes, every 5 minutes, every 10 minutes, every 30 minutes, or thelike). In some embodiments, the TIL value can be calculated based on twoor (optionally) three components: a bolus insulin load component, abasal insulin load component, and (optionally) a previous foodcomponent.

In operation 410, the controller device 200 can determine the bolusinsulin load at time t_(n) based on bolus dosages that have beendelivered to the patient in the recent past. In some embodiments, foreach bolus dosage dispensed within a predetermined period of time beforet_(n) (e.g., 6 hours, 7 hours, 7.5 hours, 8 hours, 10 hours, or thelike), the controller device 200 can estimate the amount of bolusinsulin that has not yet acted in the blood stream from time-decaymodels generated from pharmacodynamic data of the insulin. For example,a graph of an exemplary curve depicting the percent of insulin remainingversus time can be seen in FIG. 12. In particular, FIG. 12 illustratesan example of the insulin action curve generated from pharmacodynamicdata for the insulin stored in the cartridge 120. Thus, in thisembodiment, the bolus insulin load component of the TIL calculationrepresents the sum of all recent bolus insulin dosages wherein eachbolus insulin dosage is discounted by the active insulin function (whichmay be modeled on pharmacodynamic data as shown, for example, in FIG.12).

Still referring to FIG. 11, in operation 415, the controller device 200can determine the basal insulin load at time t_(n) based on, forexample, the previous basal rate during a predetermined period of time(e.g., 6 hours, 7 hours, 7.5 hours, 8 hours, 10 hours, or the like). Foreach basal insulin dispensation (e.g., 0.25 U dispensed every fifteenminutes, 0.5 U dispensed every fifteen minutes, 0.4 U dispensed everyten minutes, of the like), the controller device 200 can estimate theamount of basal insulin that has not yet acted in the blood stream fromtime-decay models generated from pharmacodynamic data of the insulin. Aspreviously described, FIG. 12 illustrates an example of the insulinaction curve generated from pharmacodynamic data for the insulin storedin the cartridge 120. Thus, in this embodiment, the basal insulin loadcomponent of the TIL calculation represents the sum of all recent basalinsulin dosages wherein each basal insulin dosage is discounted by theactive insulin function (which may be modeled on pharmacodynamic data asshown, for example, in FIG. 12). As described below in connection withFIG. 13, the basal insulin load at time t_(n) may approach a constantvalue if the basal dosage rate remains constant over an extended periodof time.

Optionally, the process 400 may include operation 420 in which theprevious food component is employed in the TIL calculation. Thecontroller device 200 can determine the previous food component basedon, for example, the total carbohydrates previously entered into thecontroller device 200 as being consumed by the user during apredetermined period of time before t_(n) (e.g., 6 hours, 7 hours, 7.5hours, 8 hours, 10 hours, or the like). The previous food component canbe determined, for example, by estimating the amount of carbohydratesthat have been consumed but not yet metabolized by the user's body so asto effect the blood glucose level. For each of the previous food itemsreported by the user, the controller device 200 can estimate thepreviously consumed food that has not yet been metabolized from atime-based model generated from a standard glycemic index.Alternatively, when the user enter's information regarding food intake,the user can be prompted to identify the metabolization “speed” of thefood item based on the glycemic index for that food. In thesecircumstances, the user may be prompted to input the amount of food(e.g., grams of Carbohydrate or another representative value) and thenidentify the glycemic index (via a numerical scale or from a list of twoor more choices (e.g., “fast” metabolization and “slow” metabolization)to provide a more accurate time-based function for specific meals. Whenthis yet-to-be-metabolized carbohydrate value is estimated, it can betreated as a “negative” insulin component in the TIL calculation bymultiplying the yet-to-be-metabolized carbohydrate value by acarbohydrate ratio (e.g., 1 unit of insulin per 15 grams ofcarbohydrates). In some embodiments, the calculated value for theprevious food component can be displayed separately to the user (e.g.,to provide the user with information regarding the effects of thepreviously consumed carbohydrates).

Still referring to FIG. 11, in operation 425, the TIL at time t_(n) canbe calculated by summing the bolus insulin load, the basal insulin load,and (in some embodiments) the previously consumed food component, wherethe previous food component is treated as a negative insulin unit value.In these circumstances, the TIL values may accurately reflect both thepreviously dispensed insulin that has not yet acted (to reduce orotherwise effect the blood glucose level) and the previously consumedfood that has not yet been metabolized (to increase or otherwise effectthe blood glucose level). It should be understood from the descriptionherein that, in alternative embodiments, the process for determining theTIL information may not include the previous food component (asdescribed in connection with operation 420). In such embodiments, theTIL at time t_(n) can be calculated by summing both the bolus insulinload and the basal insulin load. Because this TIL determination is notbased merely on previous bolus deliveries, the TIL information mayaccurately reflect basal rate changes and the impact of stopping insulindelivery or changing insulin delivery (e.g., a temporary basal rateadjustment).

In operation 430, the TIL value can be stored in the memory of thecontroller device 200 (e.g., in the memory chip 248 or in another memorydevice coupled to the control circuitry 240). For example, thecalculated TIL value at time t_(n) can be stored in a database alongwith the time t_(n). The database may also store the current bloodglucose level at time t_(n), which may be generated from the sensorsignal received from the monitoring device 50 (FIG. 1). As described inmore detail below, the database can maintain a historical record of theTIL information, the time information, and (optionally) the detectedblood glucose information that is accessible by the controller device200 or by an external computer. In addition or in the alternative, thecontroller device 200 can be configured to perform an on-demandcalculation of the TIL value as a function of recent history by storingeach input data point (e.g., basal insulin dosages, bolus insulindosages, food intake data, etc.) and then summing each component (e.g.,the basal insulin load, the bolus insulin load, and the previouslyconsumed food component) as a function of time.

In operation 435, the TIL information can be displayed on the userinterface 220 of the pump controller device 200. The TIL information canbe retrieved from the memory device that stores the recently calculatedTIL value. In particular embodiments, the display 222 of the userinterface 220 may be configured to display a default referenceinformation screen when the user is not activating any menu screens(e.g., a reference screen that is displayed after no buttons are pressedfor a period of time). For example, as shown in FIG. 1, the display 222can indicate the time (10:30 AM in this example), the date (January 1 inthis example), the user's current blood glucose level (180 mg/dl in thisexample), an indication of whether the user's blood glucose level isrising or falling (the downward arrow indicates a decreasing glucoselevel in this example), and the recently determined TIL information (2.2U insulin load in this example). In another example, as shown in FIG. 2,the display 222 of the user interface 220 provides a default screen thatprovides the time (10:30 AM in this example), the blood glucose level(118 mg/dl in this example), the indication of whether the user's bloodglucose level is rising or falling (the upward arrow indicates a risingglucose level in this example), and the recently calculated TILinformation (a 10% load in this example, which represents a normalizedvalue of the TIL calculation as described below in connection with FIG.13).

In operation 440, the process 400 can return to initiate a new TILcalculation after a period of time. For example, the operation 440 cancause the controller device 200 to calculate the TIL for time t_(n+1) byreturning to operation 405. As previously described, the controllerdevice 200 can initiate the subsequent TIL calculation for thesubsequent time t_(n+1) based on a request from the user or based on aprogram that causes calculation of the TIL information on a periodicbasis (e.g., every 1 minute, every 2 minutes, every 5 minutes, every 10minutes, every 30 minutes, or the like). The subsequent TIL value fortime t_(n+1) can be stored in the memory of the controller device 200(e.g., in the previously described database) and can be displayed on theuser interface 220 of the controller device 200.

Referring now to FIG. 12, in some embodiments, the controller device 200can calculate the TIL information using, at least in part, time-basedmodels derived from pharmacodynamic data. As previously described, theTIL value of a user can include a bolus insulin load component and abasal insulin load component, each of which may be determined using atime-decay model generated from pharmacodynamic data associated with theinsulin stored in the cartridge 120. As shown by way of example in FIG.12, the controller device 200 can utilize a time-decay curve(represented by curve 450), which is generated from pharmacodynamicdata, to estimate the percentage of insulin remaining in a user's bodyafter a particular period of time.

Referring now to FIG. 13, graph 500 is an exemplary depiction of how aconstant basal delivery can affect a user's TIL information. In thisexample, the basal insulin deliveries are represented as a series ofbasal infusion points 506 (e.g., dosages of 0.25 U every fifteen minutesto provide a basal rate of 1.0 U per hour). It should be understood fromthe description herein that, while the basal rate is sometimes describedas a generally continuous administration, it can be implemented a seriesof small injections given at regular intervals. Because the basal rateis constant over a period of seven hours with no bolus dosages, theinsulin delivery pattern 505 is represented as a horizontal, straightline that depicts a constant basal rate of 1.0 units/hour. For thepurposes of this example, it is presumed that there were no basal orbolus insulin deliveries prior to time=0 (hours), there were nopreviously consumed carbohydrates acting on the user's total insulinload, and that the user's TIL (represented by TIL curve 510) was also0.0 prior to time=0. This may occur, for example, after the user wakesin the morning and then activates the pump assembly 60 to deliver thebasal insulin. As such, the user's TIL value has only a single component(basal insulin load) and is equal to zero before time=0. The othercomponents of the TIL calculation, such as the bolus insulin load andthe previous food component, are zero in this example. At time=0 thefirst basal infusion (represented by point 507) of 0.25 units is made.Since substantially none of the insulin delivered in the first infusion(point 507) has acted on the user at time=0, the entire contents of theinfusion (0.25 units) are now part of the TIL, which is reflected in theTIL curve 510. With the subsequent boluses 508 and 509, the TILincreases, while some small portion of the previously dispensed insulinacts in the blood stream. This is estimated from a time-decay curve(refer, for example, to FIG. 12), which is generated frompharmacodynamic data. As time increases, however, the amount of insulinleaving the insulin load and entering the blood stream increases untilpoint 512 where the amount of insulin leaving the insulin load to act inthe blood stream is substantially equal to the amount of insulinentering the insulin load due to the constant basal infusion. If thebasal rate remains constant, than the TIL will continue to remain at theequilibrium value shown on the graph 500. In this example, the TILreaches equilibrium at a value of about 2.25 U (as shown on theleft-side axis in graph 500).

In some circumstances, the TIL information can be stored, displayed, orboth as a normalized value (e.g., the TIL % value indicated on theright-side axis of the graph 500). Although the TIL value (in units ofinsulin) is a useful number, that actual value can vary from user touser depending on his or her insulin intake characteristics. The TIL %value can be used as one feature to normalize the TIL calculation forconvenient analysis or comparison between users. For example, the TIL %value can be calculated as follows:TIL % value=[(Actual TIL)−(theoretical TIL_(basal))]/(theoreticalTIL_(basal))×100,

-   -   where theoretical TIL_(basal) represents the TIL that would have        been generated based only on the user's basal insulin dosages        (e.g., presuming no bolus insulin and no previous food        components) As such, in the example depicted in FIG. 13, the TIL        % value remains at a constant of 0% (refer to TIL % curve 515)        because the actual TIL value remains equal to the theoretical        TIL_(basal) value (based only on the user's basal insulin        dosages). However, when the user receives bolus dosages and/or        or has a previous food component (such circumstances are        described in more detail below), the TIL % value may provide for        prompt analysis of the user's insulin status and provide for        easy comparison between users.

The controller device 200 can display the TIL information on the userinterface 220 as the TIL value (in units of insulin as shown, forexample, in FIG. 1), as the TIL % value (normalized to be a percentageas shown, for example, in FIG. 2), or as both the TIL value and the TIL% value. Moreover, the TIL information can be stored in a memory device(e.g., memory device 248) of the controller device 200 as the TIL value(in units of insulin), as the TIL % value (normalized to be apercentage), or as both the TIL value and the TIL % value.

Referring now to FIG. 14, the controller device 200 can calculate theTIL information based, at least in part, on both basal insulindispensations and bolus insulin dispensations. In this example, graph600 includes an insulin delivery curve 610 made up of individual basaldispensations 612 and bolus dispensations 614, 616, and 618, a TIL curve620 (which accounts for both a basal load component and a bolus loadcomponent), and a TIL % curve 630. In region 640, the basal infusionrate remains constant and no boluses are infused, so the TIL curve 620remains at it's equilibrium value while the TIL curve 630 remains at 0%(similar to the characteristics described in connection with FIG. 13).At about time=8 hours, a bolus delivery 614 of about 5 insulin units isdelivered to the user. This bolus dosage may be selected in response tothe user proposing new food intake, the user attempting to offset anelevated blood glucose level that requires correction, or the like. Thisbolus delivery 614 raises the user's TIL value to slightly higher than 7units, or about 5 units plus the equilibrium value. In region 650, theuser's TIL value decays or otherwise decreases as the previouslydispensed insulin transitions to act in the user's blood stream (e.g.,to lower or otherwise affect the user's blood glucose level). With thesubsequent boluses 616 and 618, at about time=10 and time=12 hoursrespectively, the user's TIL value increases with each bolus, andthereafter decays.

As shown in FIG. 14, the TIL % value is also affected by the bolusdeliveries 614, 616, and 618. For example, the TIL % curve 630 indicatesthat the TIL % value increases from 0% to about 222% immediately afterthe first bolus delivery 614. Although the TIL value (in units ofinsulin, represented in curve 620) is a useful number, that value mayvary from user to user depending on his or her insulin intakecharacteristics (e.g., type of insulin, insulin sensitivity,carbohydrate ratio, overall insulin requirements, or the like). Here,the TIL % value of about 222% represents a normalized value forconvenient analysis by the user or a health care provider. Inparticular, this normalized value indicates to the user that the TIL ismore than two times (e.g., 222%) what it would ordinarily be if the userhad maintained just the constant basal rate (from region 640) withoutany bolus delivery 614). In region 650, the user's TIL % value decays orotherwise decreases as the previously dispensed insulin transitions toact in the user's blood stream (e.g., to lower or otherwise affect theuser's blood glucose level). With the subsequent boluses 616 and 618, atabout time=10 and time=12 hours respectively, the user's TIL % valueincreases with each bolus, and thereafter decays.

Referring now to FIG. 15, as previously described, the TIL informationcan be determined in a manner that accounts for both the bolusdeliveries and the basal deliveries (not merely previous bolusdeliveries). As such, the TIL values may accurately reflect basal ratechanges and the impact of stopping insulin delivery (e.g., duringperiods in which insulin delivery is stopped or basal delivery isaltered, during activities such as swimming or another exercise, etc.).The insulin delivery pattern in FIG. 15 is similar to the previouslydescribed scenario shown in FIG. 14, except that the basal delivery isstopped between time=5 hours and time=7 hours (refer to the basaldelivery curve 710 in graph 700). For example, the graph 700 includes aregion 740, in which the basal infusion rate remains constant and noboluses are infused, so the TIL curve 720 approaches a constant valuewhile the TIL % curve 730 remains at 0% (similar to the previouslydescribed scenario shown in FIG. 14). At about time=5 hours, basaldelivery is suspended for a period of approximately two hours (refer toregion 750). As a result, the TIL curve 720 decays or otherwise reducesin that period of time because the previously dispensed insulintransitions to act in the user's blood stream (e.g., to lower orotherwise affect the user's blood glucose level) and no further insulinis being dispensed during that time period. Also, in the exampledepicted in FIG. 15, the TIL % curve 730 transitions into negativevalues (e.g., −25%, −50%, etc.) because the insulin dosages were ceasedbetween time=5 hours and time=7 hours. During such periods of ceasedinsulin delivery, the actual TIL value may become less than theoreticalTIL_(basal) (e.g., the TIL that would have been generated based on theuser's basal insulin dosages), which causes the TIL % values totransition into negative values. In one example, the user may readilyrecognize that his or her insulin load (e.g., TIL %=−25%) isapproximately ¼ th less than what it normally would have been if he orshe had maintained the scheduled basal insulin delivery rate.Accordingly, the TIL values and the TIL % values can accurately reflectbasal rate changes and the impact of stopping insulin delivery.

As shown in FIG. 15, the basal insulin rate restarts at about time=7hours, which causes the TIL value to increase and the TIL % value toreturn toward 0%. In this example, a bolus delivery 714 of about 5 unitsis delivered to the user at about time=8 hours, thereby raising theuser's TIL value about 5 units to slightly higher than 6 units. Such abolus delivery 714 also causes the TIL % value to increase to slightlyless than 200% in this example. This normalized value indicates to theuser that the TIL is slightly less than two times what it wouldordinarily be if the user had maintained just the constant basal rate(from region 740) without any bolus delivery 714. In region 760, theuser's TIL value and the TIL % value decays or otherwise decreases asthe previously dispensed insulin transitions to act in the user's bloodstream (e.g., to lower or otherwise affect the user's blood glucoselevel). With subsequent bolus deliveries 716 and 718 at about time=10and time=12 hours respectively, the user's TIL value and the TIL % valueincreases with each bolus, and thereafter decays.

Referring now to FIG. 16A, the TIL value may return to a constant value(and the TIL % value may return to 0%) after an extended period of timewith no bolus activity. For example, the graph 800 in FIG. 16A issimilar to the previously described graph in FIG. 15, except that itshows the insulin delivery pattern over a greater duration of time. Insome embodiments, a user may continue to receive insulin deliveries fromthe pump assembly 60 during his or her period of sleep. The user canreceive only his or her ordinary basal dosages during this period ofsleep so as to maintain his or her blood glucose level within a saferange. In the example depicted in FIG. 16A, the user receives a bolusdelivery 819 before a dinner meal at about time=18 hours. Thereafter, nofurther bolus dosages are provided for the remainder of the day, and theuser receives only the ordinary basal rate delivery (refer to region 870in FIG. 16A). During this extended period of receiving only the basaldeliveries as shown in region 870, the TIL values (refer to TIL curve820) decay or otherwise decrease from a value greater than 10 units ofinsulin to a constant value of slightly greater than 2 units. Also,during this extended period in region 870, the TIL % values (refer toTIL % curve 830) decay or otherwise decrease from a normalized value ofalmost 400% to the constant value of 0%. Accordingly, over a period of aday or more, the TIL value and the TIL % value can “reset” or otherwisereturn to a constant value during periods of sleep (when the userreceives nighttime basal dosages) or during other extended periodsduring which no bolus activity occurs.

In the previous examples, described in connection with FIGS. 14-16A, thecontroller device 200 calculated the TIL at any given time by summingthe insulin load due to basal delivery and the insulin load due to oneor more bolus deliveries (if any). These examples depict embodiments ofthe controller device 200 that provide the advantage of using moreaccurate insulin action curves to estimate the amount of insulin thathas been delivered to a user (but not yet acted in that user's bloodstream), and the advantage of including a basal insulin load componentto the TIL calculation (thus incorporating all delivered insulin in theTIL calculation). As described previously, a calculated TIL value can beused to, for example, predict future blood glucose levels and/or can beused in the calculation of suggested bolus amounts. As such, thecontroller device 200 can employ the TIL information to provide accurateinformation to the user and to avoid “bolus stacking” and unsafe swingsin blood glucose level.

In much the same way that insulin does not immediately enter the bloodstream and act upon a user after subcutaneous delivery, ingestedcarbohydrates can also take time to fully act upon the user's bloodglucose level. In some embodiments, the controller device 200 can alsoinclude a component in the TIL calculation that takes into account foodwhich has been previously consumed but not yet acted in the user.

Referring now to FIG. 16B, as previously described, the TIL informationcan account for the user's previously consumed food in addition to thebolus deliveries and the basal deliveries. In these circumstances, theTIL values may accurately reflect both the previously dispensed insulinthat has not yet acted and the previously consumed food that has not yetbeen metabolized. The insulin delivery pattern in FIG. 16B is similar tothe previously described scenario shown in FIG. 16A, except that theuser in FIG. 16B skips a bolus delivery at time=12 hours (note that FIG.16A shows a bolus delivery 816 at time=12 hours). Also, in the exampledepicted in FIG. 16, the TIL calculation process also accounts forpreviously consumed food (e.g., the previous food component). Forexample, the graph 900 in FIG. 16B includes a basal delivery curve 910made up of individual basal infusions 912, a TIL curve 920, and a TIL %curve 930. At about time=12 hours, the user enters meal data into thecontroller device 200, but no bolus delivery is dispensed (e.g., due touser error or another reason), leading to an immediate drop in the TILcurve 920 and the TIL % curve 930. This substantial decrease in the TILvalue and the TIL % value is due to the fact that the process forcalculating the TIL information accounts for the user's previouslyconsumed food intake (in addition to the bolus deliveries and the basaldeliveries). Thus, the controller device 200 receives information attime=12 hours that the user has consumed food but no bolus delivery wasprovided (e.g., a “missed bolus” situation). As such, the previous foodcomponent of the TIL calculation becomes much more significant than thebolus load component and the basal load component (thereby driving theTIL value and the TIL % value into the negative value range). In someembodiments, this drop of the TIL curve 920 into the negative regioncould result in the controller device 200 alerting the user to apotentially unsafe condition (e.g., a significant rise in blood glucoselevel) long before the user's blood glucose level begins to rise outsideof a targeted range. Such a safety feature can provide enhancedprotection for the user, who would have the opportunity to select acorrection bolus before the blood glucose level increased to unsafeconditions.

Still referring to FIG. 16B, at about time=18 hours, a bolus delivery915 is provided to the user, but no meal data is entered into thecontroller device 200. Unlike the previous situation at time=12 hours inwhich the user missed a bolus dosage, this may represent a “missed meal”situation at time=18 hours. This situation may occur, for example, wherethe user intends to eat a meal and schedules a bolus dosage, but thenforgets or fails to consume the proposed meal. Such conditions can leadto a sharp increase in the TIL curve 920 and the TIL % curve 930. Assuch, the bolus load component of the TIL calculation becomes much moresignificant than the previous food component (thereby driving the TILvalue and the TIL % value upward into the higher value range). In someembodiments, this sharp increase of the TIL curve 920 could result inthe controller device 200 alerting the user to a potentially unsafecondition (e.g., a significant drop in blood glucose level) long beforethe user's blood glucose level begins to fall outside of a targetedrange. Such a safety feature can provide enhanced protection for theuser, who would have the opportunity to consume food items and enter thefood data in the controller device 300 before the glucose leveldecreased to unsafe conditions. If the user did consume food at abouttime=18 hours but merely forgot to enter the information into thecontroller device 200, the user would have the opportunity to enter themeal information, thus causing the next TIL calculation to be corrected.For example, in response to the alert from the controller device 200,the controller device may prompt the user to enter the previous foodinformation (if he or she forgot to enter the meal information) or tostart the consumption of food items.

Similar to embodiments previously described in connection with FIG. 16A,the TIL value may return to a constant value (and the TIL % value mayreturn to 0%) after an extended period of time with no bolus activityand no food consumption activity. In this example shown in FIG. 16B,during the period between time=18 hours and time=24 hours, the user maycease bolus activity and food consumption (e.g., as he or she preparesfor sleep and begins to sleep overnight). During this extended period ofreceiving only the basal deliveries as shown in region 970, the TILvalues (refer to TIL curve 920) decay or otherwise decrease to aconstant value of slightly greater than 2 units. Also, during thisextended period in region 970, the TIL % value (refer to TIL % curve930) decay or otherwise decrease to a constant value of 0%.

Referring now to FIG. 17, some embodiments of a process 1000 for thecalculation of a suggested bolus amount can include a number ofoperations performed by the controller device 200 in response to userinput. For example, when the user intends to consume a meal, the usercan select a bolus insulin delivery to offset the blood glucose effectscaused by the carbohydrates consumed with the meal. In another example,a user's blood glucose may be significantly higher than a targetedlevel, so the controller device 200 can suggest a correction bolusamount that will lower the blood glucose level into an acceptable range.As described in connection with FIG. 17, the controller device 200 canalso take into account the user's TIL information when calculating thesuggested bolus amount to the user.

In operation 1005, the controller device 200 can receive a request tosuggest a bolus dosage. An exemplary request can come from the user thatinteracts with the user interface 220 of the controller device 200. Forexample, the user may request a suggested insulin bolus amount duringpreparation for a proposed meal. As described below, the suggested bolusvalue can be calculated from at least three components: a food bolusvalue (to offset the blood glucose effects caused by the proposed meal),a correction bolus value (to reduce the current blood glucose level intoan acceptable range), and the TIL value (as previously described inconnection with FIG. 11).

In operation 1010, the controller device 200 can receive input from theuser indicating the amount of food to consumed. For example, the usercan enter the amount and type of food that is to be consumed and thecontroller device 200 can determine the amount of carbohydratescontained in the food to be consumed. In another example, the user candetermine the amount of carbohydrates in a proposed meal and enter thisvalue into the controller device 200 (e.g., grams of carbohydrates orthe like). In operation 1015, the controller device 200 can calculatethe amount of bolus insulin to offset the proposed food intake asentered in operation 1010 (e.g., the food bolus value). For example, thenumber of carbohydrates determined in operation 1010 can be divided by acarbohydrate ratio (e.g., 15 grams of carbohydrates per 1 unit ofinsulin) to determine the dosage of bolus insulin to offset thepotential blood glucose effects caused by the proposed meal.

In operation 1020, the controller device 200 can receive informationindicative of the user's current blood glucose level. For example, thecontroller device 200 can receive information indicative of the user'sblood glucose level from the glucose monitoring device 50. In anotherexample, the user can utilize a separate blood glucose meter (e.g., ablood strip reader) and enter the results into the controller device200. Alternatively, the glucose meter device can wirelessly communicatethe blood glucose information to the controller device 200 (viacommunication with wireless device 247).

In operation 1025, the controller device 200 can calculate the amount ofinsulin (if any) to correct the current blood glucose level based on theinformation obtained during operation 1020. For example, the controllerdevice 200 can subtract the user's target blood glucose level from thecurrent level obtained during operation 1020, and then multiply thisdifference by an insulin sensitivity factor. Such a calculation canprovide a correction bolus value that is indicative of the amount ofinsulin that is appropriate to reduce the current blood glucose levelinto an acceptable range. A positive correction bolus value indicatesthat the current blood glucose level is high, thereby requiringadditional insulin to correct. Conversely, a negative correction bolusvalue indicates that the current blood glucose value is low, which willcause the suggested total bolus to be decreased.

In operation 1030, the controller device 200 can retrieve a TIL valuestored in memory (previously described in connection with FIG. 11). Toreduce the likelihood of undesirable bolus stacking, the TIL informationcan be determined by the controller device 200 on a periodic basis sothat the user can be aware of the previously dispensed insulin which hasnot yet acted in the user's body. This TIL information can be used in abolus suggestion feature of the controller device 200 so that thesuggested bolus amount accounts for the previously dispensed insulin(both basal and bolus dosages) which has not yet acted in the user'sbody and (optionally) the previous food intake of the user. The TILvalue can be stored in a memory device 248 (FIG. 9) of the controllerdevice 200. As an alternative to retrieving the TIL value from thememory device, the controller device 200 can calculate a current TILvalue using a process, for example, as previously described inconnection with FIG. 11).

In operation 1035, the controller device 200 can calculate a suggestedbolus dosage based, at least in part, on the information provided by theuser. In one example, the suggest bolus dosage can be determinedaccording to the following equation:Suggested Bolus Dosage=Food Bolus+Correction Bolus−TIL Value

As such, the controller device 200 can provide a bolus suggestionfeature that accounts for the user's TIL when suggesting a new bolus ofinsulin prior to a meal or other food intake. By so including the TILinformation in the suggested bolus calculation, which accounts for theamount of previous basal and bolus insulin that has not yet acted in theuser's body, the controller device 200 can reduce the likelihood of theuser performing an unsafe level of bolus stacking. Moreover, in someembodiments, the TIL information can reflect the user's previouslyconsumed food in addition to the bolus deliveries and the basaldeliveries. Accordingly, the suggested bolus calculation, which includesthe TIL information, can account for both the previously dispensedinsulin that has not yet acted and the previously consumed food that hasnot yet been metabolized.

In operation 1040, the controller device 200 can inform the user (e.g.,through display device 200, through an audio output, or through anothercomponent of the user interface) of the bolus suggestion. In oneexample, the display device 222 can communicate the suggested bolusamount to the user so that the user can manually input the suggestedbolus value into a bolus scheduling module of controller device 200(e.g., a separate menu option). Alternatively, as indicated in operation1045, the controller device 200 can prompt the user to begin bolusdelivery according to the suggested bolus dosage. For example, thecontroller device 200 can display the suggested bolus value along with aprompt that asks the user to confirm the start of the suggested bolusdosage. If the user responds in the affirmative, the controller device200 can automatically begin the infusion. If the user responds in thenegative, the user can have the opportunity manually input the suggestedbolus value into a bolus scheduling module of controller device 200(e.g., a separate menu option).

Referring now to FIGS. 18-19, in some circumstances, the TIL informationthat is collected over a period of time can be accessed by the user or ahealth care provider for purposes of analysis and program adjustments.As previously described, the TIL information at time t_(n) and the timedata t_(n) can be stored in the memory of the controller device 200. Thememory of the controller device 200 may also store the detected bloodglucose level at time t_(n), which may be generated from the sensorsignal received from the monitoring device 50 (FIG. 1). As such, thedata stored in the controller device 200 can provide a historical recordof the TIL information, the time information, and (optionally) thedetected blood glucose information that is accessible by the controllerdevice 200 or by an external computer system (e.g., a desktop computer,a laptop computer, a PDA, or the like).

For example, as shown in FIG. 18, the controller device 200 can storethe TIL information and other data related to a user's blood glucoselevel in the memory device 248 (FIG. 9) and subsequently transfer thisdata to an external computer system 80 of the user or the user's healthcare provider. In some embodiments, the external computer system 80 candisplay a plot of the historical data and (optionally) execute asoftware program to analyze the historical data for the purposes ofhelping the user to better manage his or her diabetes treatment. Thisanalysis can be used, for example, to educate the user about thebenefits of entering meal information in an accurate and timely manner,to properly adjust the user's basal rate schedule, to modifyuser-specific parameters programmed in the controller device 200 (e.g.,the carbohydrate ratio, insulin sensitivity, and the like), and toperform other management tasks.

In this illustrative example depicted in FIG. 18, the controller device200 may communicate data to an external computer system 80 via a dataconnection 85. As previously described, the controller device 200 mayinclude a cable connector (e.g., a USB connection port, another datacable port, or a data cable connection via the electrical connection218) that is accessible on an external portion of the controller housing210. As such, a data cable may be connected to the control circuitry 240to export the data to the external computer system 80. Alternatively,the data connection 85 can be a wireless connection via the controller'swireless communication device 247. In such circumstances, the wirelesscommunication device 247 can be configured to wirelessly communicatewith the monitoring device 50 (FIG. 1) and with the external computersystem 80 (FIG. 18). When the controller device 200 is connected to thecomputer system 80 via the data connection 85, the controller device 25can execute a data exporting module in which the TIL information, thetime information, the detected blood glucose information, and othertreatment information is exported in a suitable format to the externalcomputer system 80. In some circumstances, the controller device 200 maybe detached from the pump device during the process of exporting data,so the controller device 200 can suspend dispensation operations (e.g.,suspends basal infusion, bolus infusion, accessibility to certain menusvia the user interface 220, and the like). While controller deviceexecutes the data exporting module, the controller device 200 mayindicate on the display device 222 that the controller device 200 is inthis mode by displaying a message such as “Exporting Data . . . ” or thelike.

Still referring to FIG. 18, after the data has been transferred to thecomputer system 80, the computer system 80 can display the TILinformation and other treatment data is a usable format. For example,the display device of the computer system 80 can provide a time-basedplot 82 that indicates the user's insulin delivery pattern 84 and theuser's TIL information 86 with respect to time. The TIL information inthe plot 82 can be display as the actual TIL value (in units ofinsulin), the TIL % value (normalized to be a percentage), or both. Thecomputer system 80 may provide a time-based plot that indicates theuser's detected blood glucose levels with respect to time. Optionally,this blood glucose information can be display on the same plot 82 as theTIL information 86. Thus, the external computer system 80 can displaythe plot 82 of the user's historical treatment data and may optionallyexecute a software program to analyze the historical treatment data forthe purposes of helping the user to better manage his or her diabetestreatment. By presenting the TIL information and other treatment data tothe user in an understandable, graphical format (such as the time-basedplot 82), the health care provider is readily equipped to educate theuser about the benefits of entering meal information in an accurate andtimely manner, to properly adjust the user's basal rate schedule, tomodify user-specific parameters programmed in the controller device 200(e.g., the carbohydrate ratio, insulin sensitivity, and the like), andto perform other management tasks.

In another illustrative example depicted in FIG. 19, some embodiments ofthe controller device 200 can be configured to display the TILinformation and other treatment data is a graphical format data on thelocal display device 222. For example, as shown in FIG. 19, thecontroller device 200 can access the historical treatment data stored inthe memory device 248 so as to generate a graphical representation 226of the TIL information over a period of time. In this embodiment, theTIL information is displayed on the display device in the form of a bargraph 226 that indicates the user's TIL information over a period ofhours. The display device 22 can be configured to display a y-axis thatis representative of the scale for the TIL value of the TIL % value.Also, the display device 222 can shows a set of time increments along anx-axis of the bar graph 226. As such, the controller device 200 canprovide prompt access to the TIL information by a user or health careprovider, and can readily present such information in an understandable,graphical format (such as the time-based plot 226). In doing so, theuser can assess his or her insulin treatment performance over a recentperiod of time and make proper adjustments to his or her basal rate,bolus dosages, eating schedule, or the like. In the event that the userseeks to review the TIL information over a longer period of time, thecontroller device 200 can display the TIL values for this extendedperiod (e.g., a 24-hour period) on the display device 222 by averagingthe TIL values during each one hour period into a single value. In suchcircumstances, the hour-averaged values (e.g., 24 averaged values for a24 hour period) can then be displayed in a graphical format, such as bargraph, that indicates the trends of the user's TIL information.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention.Accordingly, other embodiments are within the scope of the followingclaims.

What is claimed is:
 1. A medical infusion pump system, comprising: aportable pump housing that receives insulin for dispensation to a user,the pump housing at least partially containing a pump drive system todispense the insulin through a flow path to the user; a controller thatactivates the pump drive system to dispense the insulin from theportable pump housing, wherein the controller is configured to receiveglucose information being indicative of a blood glucose level of theuser; and a user interface coupled to the controller including a displaydevice that contemporaneously displays a glucose value indicative of theblood glucose level of the user and a total insulin load indicative ofbolus and basal insulin dosages that have dispensed but not yet acted inthe user.
 2. The system of claim 1, wherein the display devicecontemporaneously displays the glucose value and the total insulin loadin a reference information screen that is displayed when the user hasnot activated any menu options for a particular period of time.
 3. Thesystem of claim 1, wherein the total insulin load is determined by thecontroller according to a function that accounts for (i) a bolus insulinload indicative of one or more bolus insulin dosages that have beendispensed into the user but not yet acted in the user, (ii) a basalinsulin load indicative of one or more basal insulin dosages that havebeen dispensed into the user from the portable infusion pump system butnot yet acted in the user; and (iii) a previous food component basedupon previous food intake that has not yet metabolized in the user. 4.The system of claim 1, further comprising a computer-readable memorydevice coupled to the controller that stores one or more calculatedvalues for the total insulin load and one or more corresponding timevalues.
 5. The system of claim 4, wherein the controller furthercomprises a data connection instrument to export the calculated valuesfor the total insulin load and the corresponding time values to anexternal computer system.
 6. The system of claim 5, wherein when thecontroller exports the calculated values for the total insulin load andthe corresponding time values to the external computer system, theexternal computer system displays the calculated values for the totalinsulin load in a time-based plot.
 7. The system of claim 1, wherein theuser interface includes the display device and a plurality ofuser-actuatable buttons.
 8. The system of claim 7, the display devicecontemporaneously displays the glucose value and the total insulin loadin a default screen that is displayed when the user has not actuated anyof the buttons for a particular period of time.
 9. The system of claim8, wherein the total insulin load is determined by the controlleraccording to a function that accounts for at least (i) a bolus insulinload indicative of one or more bolus insulin dosages that have beendispensed into the user but not yet acted in the user, and (ii) a basalinsulin load indicative of one or more basal insulin dosages that havebeen dispensed into the user from the portable infusion pump system butnot yet acted in the user.
 10. The system of claim 1, wherein thecontroller comprises a controller housing that removably attaches to thepump housing, the controller being electrically connected to the pumpdrive system when the controller housing is removably attached to thepump housing.
 11. The system of claim 10, wherein the controller is areusable device, and wherein the pump housing and pump drive system arecomponents of a disposable and nonreusable pump device having one ormore structures that hinder reuse of the pump device after a supply ofthe insulin is exhausted.
 12. The system of claim 1, wherein theportable pump housing receives a prefilled cartridge of the insulinthrough an opening in the pump housing that is coverable with a capdevice, and the flow path of the insulin comprises and an infusion settube that extends from the cap device to the user.
 13. The system ofclaim 1, further comprising a monitoring device that communicates theglucose information to the controller which indicative of a bloodglucose level of the user.
 14. The system of claim 1, wherein themonitoring device comprises a portable housing wearable on the user'sskin, a sensor shaft that penetrates into the user's skin, and awireless communication device to transmit the glucose information to awireless communication device of the controller.
 15. A medical infusionpump system, comprising: a portable pump housing that receives insulinfor dispensation to a user, the pump housing at least partiallycontaining a pump drive system to dispense the insulin through a flowpath to the user; a controller that activates the pump drive system todispense the insulin from the portable pump housing, wherein thecontroller is configured to receive glucose information being indicativeof a blood glucose level of the user, and wherein controller isconfigured to determine a total insulin load indicative of bolus andbasal insulin dosages that have dispensed but not yet acted in the user,the total insulin load being determined by the controller according to afunction that accounts for at least (i) a bolus insulin load indicativeof one or more bolus insulin dosages that have been dispensed into theuser but not yet acted in the user, and (ii) a basal insulin loadindicative of one or more basal insulin dosages that have been dispensedinto the user from the portable infusion pump system but not yet actedin the user; and a user interface coupled to the controller including adisplay device that displays the total insulin load indicative of bolusand basal insulin dosages that have dispensed but not yet acted in theuser.
 16. The system of claim 15, wherein the display device of the userinterface coupled to the controller contemporaneously displays saidglucose value indicative of the blood glucose level of the user and saidtotal insulin load indicative of bolus and basal insulin dosages thathave dispensed but not yet acted in the user.
 17. The system of claim16, wherein the display device contemporaneously displays the glucosevalue and the total insulin load in a reference information screen thatis displayed when the user has not activated any menu options for aparticular period of time.
 18. The system of claim 15, wherein thecontroller comprises a controller housing that removably attaches to thepump housing, the controller being electrically connected to the pumpdrive system when the controller housing is removably attached to thepump housing, and wherein the portable pump housing receives a prefilledcartridge of the insulin through an opening in the pump housing that iscoverable with a cap device, and the flow path of the insulin comprisesand an infusion set tube that extends from the cap device to the user.19. The system of claim 18, wherein the controller is a reusable device,and wherein at least one structure is coupled to the pump housing or thepump drive system to prevent reuse of the pump housing or the pump drivesystem with a second prefilled cartridge.
 20. The system of claim 15,further comprising a monitoring device that communicates the glucoseinformation to the controller which indicative of a blood glucose levelof the user, wherein the monitoring device comprises a portable housingwearable on the user's skin, a sensor shaft that penetrates into theuser's skin, and a wireless communication device to transmit the glucoseinformation to a wireless communication device of the controller.